CLASS II Device recall · Reported 14 Feb 2018 · FDA Enforcement Report

Xhibit Telemetry Receiver recalled by Spacelabs Healthcare

Spacelabs Healthcare is recalling Xhibit Telemetry Receiver, distributed in Georgia, Michigan, New Jersey, Virginia. The recall was initiated on 17 Jan 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290

Quantity recalled12 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0532-2018
FDA event ID: 78989
Recalling firm: Spacelabs Healthcare, Snoqualmie, WA
Classification: Class II
Status: Terminated
Recall initiated: 17 Jan 2018
FDA classified: 5 Feb 2018
Reported: 14 Feb 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

17 Jan 2018	Recall initiated by company
5 Feb 2018	Classified by FDA	+19 days
14 Feb 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.

Where it was distributed

US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France

Georgia Michigan New Jersey Virginia

Questions about this recall

Why was it recalled?

Spacelabs has received multiple complaints reporting telemetry beds dropping off the Spacelabs Central Station resulting in a loss of monitoring.

Which lots are affected?

Serial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290

Where was it sold?

US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Spacelabs Healthcare

All 47

Reported	Class	Recall	Company	Reason	Where
19 Aug 2026Device	CLASS II	Xhibit Central Station recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
13 May 2026Device	CLASS II	Spacelabs Ultraview SL Command Module SL Command Module recalled	Spacelabs Healthcare	Packaging Defects	Nationwide
15 Apr 2026Device	CLASS II	Multi-parameter Command Module recalled by Spacelabs Healthcare	Spacelabs Healthcare	Labeling Errors	Nationwide
12 Nov 2025Device	CLASS II	Sentinel V11 recalled by Spacelabs Healthcare	Spacelabs Healthcare	Device Malfunction	Nationwide
22 Oct 2025Device	CLASS II	Branding is not applied to this product DVI display cables recalled	Spacelabs Healthcare	Device Malfunction	Nationwide

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9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide